Cervical Cancer Screening (Pap cytology, high-risk HPV testing, and co-testing)
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Defines coverage criteria for cervical cancer screening including age-based intervals, high-risk groups, documentation requirements, and technologies not meeting coverage for Blue Cross Blue Shield - Tennessee members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Cervical Cancer Screening
inv-01: Covered indications
Covered when ALL of the following age- and risk-based rules apply as specified:
inv-02: Covered when guideline criteria met
Coverage aligns with guideline-based screening intervals and special population recommendations; covered when criteria below are met.
(USPSTF 2018)
(USPSTF 2018)
(ACS 2020)
(USPSTF; ASCCP)
(ASCCP / specialty guidance)
(ACOG guidance)
Routine cervical cancer screening for individuals older than 65 years who are not high-risk does not meet coverage criteria when an adequate screening history is documented. Adequate screening history is defined as either three consecutive negative Pap smears or two consecutive negative HPV tests within 10 years with the most recent test within 5 years. Claims for routine screening in this population may be denied if these criteria are met.
Cervical cancer screening in individuals who have undergone a total hysterectomy (surgical removal of the uterus and cervix) with no history of cervical cancer or pre-cancer (CIN2+) does not meet coverage criteria. The policy specifies that vaginal cytology (Pap) or HPV screening should not be performed routinely in these post-hysterectomy patients when there is no history of high-grade dysplasia or cancer.
Inclusion of low-risk HPV genotypes in co-testing or other screening technologies is not covered because the clinical utility of testing for low-risk HPV types has not been established. Ordering screening tests that include low-risk HPV strains is discouraged and may be considered non-covered.
Do not perform cervical cytology (Pap) or HPV screening in patients younger than 21 years who have a normal immune system. For adolescents and young adults without immunocompromise, routine screening is not indicated and should be avoided per referenced guidance.
Consistent with ASCCP Choosing Wisely guidance, cervical cytology (Pap tests) and HPV screening should not be performed in patients under age 21 years with a normal immune system. This aligns with recommendations to avoid low-value screening in this age group.
Routine screening after a hysterectomy that included removal of the cervix and without a history of cervical precancer or cancer is considered not medically necessary and does not meet coverage criteria. Similarly, routine screening is not recommended for those older than 65 years with an adequate prior screening history, and such services may be denied.
The U.S. Preventive Services Task Force (USPSTF) recommends against cervical cancer screening for women younger than 21 years and for women older than 65 years who have had adequate prior screening, and also recommends against routine screening after hysterectomy in patients with no history of high-grade lesions. These USPSTF (Grade D) recommendations support noncoverage in those scenarios.
Avoid ordering screening tests that include low-risk HPV types; ASCCP and other professional guidance advise against testing for low-risk HPV strains because their use lacks demonstrated clinical benefit in cervical cancer screening.
Referenced Assays and Code References
| FDA-approved assays (examples) | APTIMA HPV Assays (Gen-Probe), COBAS HPV Test (Roche), Cervista and GENFIND (Hologic), BD Onclarity HPV Assay |
| BD Onclarity | FDA-approved HPV assay detecting 14 high-risk genotypes (referenced device) |
| Cobas HPV | Cobas HPV assay referenced for use on Cobas 6800/8800 systems (FDA cited) |
Provider Actions, Documentation, and Prior Authorization
Prior Authorization and Test Approvals
Prior authorization and approvals: Some cervical cancer screening tests require use of FDA-cleared/approved assays per guideline recommendations. Prior authorization may be required when an FDA-approved test is specifically requested by the provider or when the member’s benefit plan defines approvals for specific laboratory methods. Providers should verify member coverage and submit prior authorization requests when the plan requires it. If alternative (non-FDA-cleared) assays are proposed, include rationale and supporting clinical documentation with the authorization request.
- Verify member benefits and prior authorization requirements before ordering HPV testing.
- When an FDA-approved HPV assay is available and medically appropriate, document use of FDA-cleared assays per guideline recommendations.
- If requesting coverage for a non-FDA-cleared test, include clinical justification and supporting literature with the prior authorization submission.
LDT Validation and Regulatory Requirements
Laboratory-developed tests (LDTs) and validation: LDTs used for HPV or other cervical cancer screening must be validated and performed in-house under CLIA '88 as high-complexity tests. LDTs are not FDA-cleared or -approved; however, CMS regulates these tests through CLIA. When ordering or billing for LDTs, providers should document that the performing laboratory follows CLIA validation and quality requirements. Include test method, validation status, and lab CLIA certification information in the record or authorization materials when requested.
- LDTs must be validated and performed as high-complexity tests under CLIA '88.
- FDA clearance is not required for clinical use of LDTs, but documentation of CLIA validation should be available.
- When submitting prior authorization or medical necessity documentation for LDTs, include the laboratory’s validation statement and CLIA certification details.
Documentation Requirements and Denial Risk
Documentation and denial risk: Document patient age, immunocompromised status, prior cervical cancer/dysplasia history, organ transplant history, prior screening results, and rationale for testing. Screening outside recommended age ranges (younger than 21 or older than 65 with adequate prior screening) or after total hysterectomy without relevant history may be denied as not meeting coverage criteria. Ensure adequate screening history is clearly recorded (three consecutive negative Pap smears or two consecutive negative HPV tests within 10 years, most recent within 5 years) when claiming cessation criteria.
- Document adequate screening history when applicable: three consecutive negative Pap smears OR two consecutive negative HPV tests within 10 years (most recent within 5 years).
- Record patient risk factors: immunocompromised status, prior high-grade lesions or cervical cancer, DES exposure, organ transplant history.
- Avoid screening claims for individuals <21 years or >65 years (with adequate prior screening) or for individuals post-total hysterectomy without relevant history; these are at high risk for denial.
Background and Rationale
Background: Cervical cancer screening aims to detect precancerous lesions and cancer primarily through cytology (Pap), high-risk HPV testing, and reflex procedures such as colposcopy when indicated. Professional societies and guideline statements referenced in this policy emphasize testing for high-risk HPV types rather than low-risk types and outline age- and risk-based criteria for when screening is appropriate.
Definitions and Abbreviations
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